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Nedaplatin plus docetaxel ‘new standard of treatment’ for advanced squamous lung carcinoma
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CHICAGO — Nedaplatin plus docetaxel conferred significantly improved OS rates compared with cisplatin plus docetaxel in patients with advanced or relapsed squamous cell lung carcinoma, according to the results of a phase 3 study presented at the ASCO Annual Meeting.
“Limited progress has been made for the treatment of advanced squamous cell lung cancer compared with non-squamous non–small cell lung cancer,” Takehito Shukuya, MD, of the department of respiratory medicine at Juntendo University in Tokyo, said during a presentation. “Cisplatin plus docetaxel is the current standard of care in patients with advanced squamous cell lung cancer."
Nedaplatin (Aqupla, Shionogi & Co) is a second-generation platinum compound that produces a reduced rate of certain adverse events — including nausea, vomiting and nephrotoxicity — compared with cisplatin. A previous phase 2 study of nedaplatin plus docetaxel demonstrated encouraging outcomes with acceptable toxicity for patients with advanced squamous cell lung carcinoma, according to study background.
Shukuya and colleagues evaluated data from 349 patients (age range, 20-74 years) with advanced (stage IIIB or IV) or postoperatively relapsed squamous cell lung carcinoma.
Researchers assigned patients to receive 60 mg/m2 docetaxel plus IV nedaplatin (100 mg/m2; n = 177) or cisplatin (80 mg/m2; n = 172) every 3 weeks for up to six cycles.
OS served as the primary endpoint. PFS, response rate and adverse events profile served as secondary points.
Researchers observed a significantly higher OS rate among patients assigned nedaplatin plus docetaxel compared with patients assigned the standard chemotherapy regimen (13.6 months vs. 11.4 months; HR = 0.81; 90% CI, 0.67-0.98).
Nedaplatin plus docetaxel also conferred a slightly higher median PFS compared with the standard chemotherapy regimen (4.9 months vs. 4.5 months; HR = 0.83; 90% CI, 0.69-1).
Researchers observed a response rate of 54.5% among patients receiving nedaplatin compared with 52.9% among patients receiving the standard chemotherapy regimen.
Nedaplatin plus docetaxel produced a different toxicity profile than cisplatin plus docetaxel. Adverse events occurred in 100% of the patient population. Ninety-one percent of patients assigned nedaplatin plus docetaxel and 89% of patients receiving the standard chemotherapy regimen experienced a grade 3 or higher adverse event.
More patients assigned the standard chemotherapy regimen experienced grade 3 or higher nausea (14.3% vs. 4%), fatigue (10.9% vs. 3.4%), hyponatremia (30.3% vs. 13.6%) and hypokalemia (8.6% vs. 2.3). Patients who received nedaplatin experienced higher rates of grade 3 or higher adverse events of neutrophils (82.5% vs. 70.3%) and platelets (9% vs. 0%).
However, researchers observed similar rates of grade 3 or higher febrile neutropenia in the standard vs. experimental arms (15.4% vs. 13.6%).
Four treatment-related deaths occurred among patients assigned nedaplatin plus docetaxel, compared with three treatment-related deaths among patients assigned the standard chemotherapy regimen.
“Nedaplatin plus docetaxel should be considered the new standard of treatment for patients with advanced or relapsed squamous cell lung carcinoma,” Shukuya said. – by Cameron Kelsall
Reference:
Shukuya T, et al. Abstract 8004. Presented at: ASCO Annual Meeting; May 29-June 2, 2015; Chicago.
Disclosure: Sanofi provided partial funding for the study. Shukuya reports receiving honoraria from AstraZeneca, Chugai Pharma, Eli Lilly and Pfizer. Please see the abstract for a list of all other researchers’ relevant financial disclosures.